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SURGICAL CAMERA INTEGRATION SYSTEM - India CDSCO Medical Device Registration

SURGICAL CAMERA INTEGRATION SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000630_bfdbcbe1cfd62435a7c61b3594510cb0_f40eef2e75b5ee2a22e204dea278d389. This device is marketed under the brand name OR1 AIR. The license holder is KARL STORZ ENDOSCOPY INDIA PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is West Delhi Division.

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CDSCO Registered
Class Class A
SURGICAL CAMERA INTEGRATION SYSTEM
UID: MFG/MD/2023/000630_bfdbcbe1cfd62435a7c61b3594510cb0_f40eef2e75b5ee2a22e204dea278d389

Brand Name

OR1 AIR

Device Class

Class A

Approving Authority

West Delhi Division

Product Information

KARL STORZ OR1AIR-IN is a state-of-the-art integration system designed to be used inside operation theatre which facilitates following functionalities, AV Integration โ€ข OR1 Air seamlessly integrates 4K,3D & FHD imaging sources in OT (OR1 AIR) and enables to route these images on surgical monitors to get best possible imaging output for advanced surgical interventions. โ€ข Image routing is also done using PIP/PAP functions enabling surgical team to evaluate images on a monitor from multiple cameras during surgery. Documentation โ€ข Data archiving and documentation is also done in 4K,3D & FHD formats in dual channel, it creates paperless environment by integrating to HIS, PACS and hospital server for optimum data transmission and storage. โ€ข It generates surgical reports for ready use of the surgical team/ patient. Communication โ€ข OR1 Air provides Live video streaming with audio talkback and bidirectional telestration, this function facilities surgical team to demonstrate expert surgical skills or guide surgeons to overcome complications faced during surgery using coloured marking/ annotations simply using computer and hospital LAN network. โ€ข Surgical team may also stablish two way video conferencing call anywhere in the world during workshops, conferences with the ease of click of a button. Patient safety โ€ข OR1 AIR system provides Patent safety surgical checklist for utmost safety of patient, check list may be used as per required surgery recording it digitally for future use creating safe and paperless environment for both patient and surgical team

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